Senior Manufacturing Engineer

Boston Scientific; George Town; On-site; MYR 60,000 - 90,000; Full time

Job summary

Boston Scientific is seeking a Process Engineer with extensive experience in manufacturing within the medical device sector to optimize production processes and enhance product quality. You will be responsible for managing equipment qualifications, developing documentation, and leading quality initiatives. This role emphasizes collaboration and leadership, contributing to innovative medical solutions that improve patient health.

Qualifications

• 9-12 years in manufacturing/process engineering, preferably in medical devices.
• Proficiency in validation protocols (IQ/OQ/PQ).
• Strong project management skills and technical documentation competence.

Responsibilities

• Identify, order, and commission key process equipment to CGMP standards.
• Develop and modify manufacturing documentation and procedures.
• Perform qualification activities for products and processes.

Skills

Problem solving

Analytical thinking

Project management

Leadership

Documentation

Validation protocols

Education

Degree in Engineering

Job description

Key Responsibilities

• Identify, order, and commission key process equipment to CGMP standards within the Operations Engineering Cycle to meet business objectives.
• Serve as the engineering process owner for the area.
• Develop and modify manufacturing documentation and procedures to support both commercial products and new product introductions, including assembly procedures and BOMs.
• Ensure new products meet business, quality, output, and cost goals.
• Develop and improve manufacturing processes to enhance product and process quality and output.
• Ensure component, assembly, tooling, and supplier specifications meet requirements.
• Perform qualification activities for products, processes, and vendors as needed.
• Support material discrepancy review and disposition activities (MRB).
• Build expertise in a field to become a recognized leader and apply this knowledge in leadership roles.
• Reduce product/process defects and improve yields by solving technical problems using engineering principles.
• Prioritize patient safety and product quality.
• Support quality initiatives such as NCEP and CAPA to meet quality goals.
• Maintain capacity models and plan for capital needs in collaboration with line supervisors.
• Train cross-functional team members, including engineers, technicians, and product builders.
• Apply project management knowledge.
• Collaborate cross-functionally and with internal/external customers.
• Develop expertise in BSC systems.
• Willingness to travel internationally for projects.

For calibration engineering roles:

• Provide calibration services ensuring measurement traceability to recognized standards.
• Serve as SME for Calibration group, audits, and calibration management systems.
• Perform calibration functions and manage calibration activities daily.
• Research, recommend, and acquire new standards and equipment, including cost analysis.
• Develop technical reports and calibration procedures; train technicians.
• Advise on equipment selection and design accommodations for calibration.
• Support calibration lab needs and environmental controls.
• Assist in departmental budgeting.
• Communicate calibration status with Operations ME.

Requirements

• Degree in Engineering.
• 9-12 years in manufacturing/process engineering, preferably in medical devices.
• Skills: Problem solving, analytical thinking, project management, leadership, documentation, validation protocols.
• Experience in product transfers, equipment qualification, process validation.
• Ability to work within a matrix organization and collaborate across sites.
• Strong project management skills and technical documentation competence.
• Proficiency in validation protocols (IQ/OQ/PQ).
• Expertise in root cause analysis and process improvement methodologies.
• Excellent communication and stakeholder management skills globally.
• Experience in product transfer is advantageous.

About Us

Boston Scientific is a global medical technology leader for over 40 years, dedicated to transforming lives through innovative medical solutions that improve patient health. Join us to make a meaningful difference worldwide.